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Impact of Aerobic Training on Sleep Quality and Aerobic Fitness in Male Patients With Pulmonary Artery Hypertension

Primary Purpose

Pulmonary Artery Hypertension

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Moderate intensity aerobic training
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pulmonary Artery Hypertension

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who were clinically stable and compensated under optimized medical therapy
  • World health organization (WHO) Classification of functional class II to III PAH
  • Patients with ejection fraction ≥ 40%
  • Non-smokers
  • body mass index ≤ 35 kg/m2

Exclusion Criteria:

  • Any patient with respiratory failure
  • unstable angina
  • renal, hepatic or neuromuscular disorders
  • history of syncopal attacks
  • uncontrolled systemic hypertension
  • peripheral vascular disease
  • serious cardiac dysrhythmias on resting ECG
  • evidence of severe COPD at pulmonary function testing,
  • any known musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise

Sites / Locations

  • Faculty of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Training group (A)

control group (B)

Arm Description

The training was a moderate intensity aerobic training on a bicycle ergo-meter(corresponding to 60% to 70% of the maximal heart rate they reach during peak oxygen uptake in the initial exercise test) for 30 to 45 min/day, 3 sessions/week for 12 weeks (36 sessions). In addition to their prescribed medications.

Control group not receiving any training . They are taking their prescribed medications only.

Outcomes

Primary Outcome Measures

Pulmonary artery systolic pressure (PASP)
Pulsed Doppler Echocardiogram for assessing PASP as calculated from the gradient across the tricuspid valve using the modified Bernoulli equation.
Subjective self-report questionnaire that assesses sleep quality
The Pittsburgh Sleep Quality Index is a subjective self-report questionnaire that assesses sleep quality over a 1-month time interval in different populations It is 5 points score (0 means normal, 5 means severe sleep disturbance)
Determining sleep patterns
Determining sleep patterns by using actigraph to assess suspected certain sleep disorders,
Measuring aerobic fitness
Level of aerobic fitness assessed by using Cardiopulmonary exercise testing (CPET) through incremental exercise intensity until voluntary exhaustion.

Secondary Outcome Measures

Full Information

First Posted
March 31, 2020
Last Updated
April 3, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04337671
Brief Title
Impact of Aerobic Training on Sleep Quality and Aerobic Fitness in Male Patients With Pulmonary Artery Hypertension
Official Title
Impact of Aerobic Training on Sleep Quality and Aerobic Fitness in Male Patients With Pulmonary Artery Hypertension: a Randomized Control Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 2, 2018 (Actual)
Primary Completion Date
November 29, 2019 (Actual)
Study Completion Date
December 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study investigated the effect of 12 weeks of aerobic training on sleep quality and aerobic fitness in patients with Pulmonary arterial hypertension(PAH).
Detailed Description
Thirty male PAH patients were included in the study. They were randomized into two equal groups; Training group (A) and Control group(B). Right ventricular systolic pressure (RVSP) measured using Doppler Echocardiography , Pittsburg sleep quality index (PSQI) questionnaire with the wrist worn actigraph used for the assessment of sleep disturbance, and Cardiopulmonary exercise testing (CPET) measurements included maximal heart rate and VO2max .All were measured before and after the study period for both groups.The training was a moderate intensity aerobic training on a bicycle ergometer (corresponding to 60% to 70% of the maximal heart rate they reach during peak oxygen uptake in the initial exercise test) for 30 to 45 min/day, 3 sessions/week for 12 weeks (36 sessions).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Artery Hypertension

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training group (A)
Arm Type
Experimental
Arm Description
The training was a moderate intensity aerobic training on a bicycle ergo-meter(corresponding to 60% to 70% of the maximal heart rate they reach during peak oxygen uptake in the initial exercise test) for 30 to 45 min/day, 3 sessions/week for 12 weeks (36 sessions). In addition to their prescribed medications.
Arm Title
control group (B)
Arm Type
No Intervention
Arm Description
Control group not receiving any training . They are taking their prescribed medications only.
Intervention Type
Other
Intervention Name(s)
Moderate intensity aerobic training
Intervention Description
The exercise program consisted of 5 minutes warm-up, 15-30 minutes of moderate aerobic exercises and 10 minutes cool-down, respectively. Frequency: 3 sessions/week , and Duration:12 weeks.
Primary Outcome Measure Information:
Title
Pulmonary artery systolic pressure (PASP)
Description
Pulsed Doppler Echocardiogram for assessing PASP as calculated from the gradient across the tricuspid valve using the modified Bernoulli equation.
Time Frame
change from baseline at 12 weeks
Title
Subjective self-report questionnaire that assesses sleep quality
Description
The Pittsburgh Sleep Quality Index is a subjective self-report questionnaire that assesses sleep quality over a 1-month time interval in different populations It is 5 points score (0 means normal, 5 means severe sleep disturbance)
Time Frame
change from baseline at 12 weeks
Title
Determining sleep patterns
Description
Determining sleep patterns by using actigraph to assess suspected certain sleep disorders,
Time Frame
change from baseline at 12 weeks
Title
Measuring aerobic fitness
Description
Level of aerobic fitness assessed by using Cardiopulmonary exercise testing (CPET) through incremental exercise intensity until voluntary exhaustion.
Time Frame
change from baseline at 12 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Males are selected because the functional capacity parameters measured maximum oxygen consumption(VO2 max) differs from males and females as it relies on body compostion , body size, amount of muscle mass and also on ventilatory parameters
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who were clinically stable and compensated under optimized medical therapy World health organization (WHO) Classification of functional class II to III PAH Patients with ejection fraction ≥ 40% Non-smokers body mass index ≤ 35 kg/m2 Exclusion Criteria: Any patient with respiratory failure unstable angina renal, hepatic or neuromuscular disorders history of syncopal attacks uncontrolled systemic hypertension peripheral vascular disease serious cardiac dysrhythmias on resting ECG evidence of severe COPD at pulmonary function testing, any known musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Cairo
ZIP/Postal Code
12316
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33604801
Citation
Atef H, Abdeen H. Effect of exercise on sleep and cardiopulmonary parameters in patients with pulmonary artery hypertension. Sleep Breath. 2021 Dec;25(4):1953-1960. doi: 10.1007/s11325-020-02286-9. Epub 2021 Feb 18.
Results Reference
derived

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Impact of Aerobic Training on Sleep Quality and Aerobic Fitness in Male Patients With Pulmonary Artery Hypertension

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